A Phase 2b, Randomised, Double-Blind, Placebo Controlled Dose Range Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults with Uncontrolled Asthma at Risk of Exacerbations (LEVANTE).
Asthma can cause wheezing, coughing, and breathlessness. Even when using regular daily preventer inhalers, some people still experience sudden flare-ups or persistent symptoms. This clinical trial, named LEVANTE, is looking at a new inhaled medicine called AZD8630. The main goal is to find out if taking AZD8630 once a day can reduce asthma attacks and improve lung function compared with a dummy medicine (a placebo). Researchers are testing a few different doses to see which one works best and is safest. The trial is open to adults aged 18 and over who still have asthma symptoms despite using regular medium-to-high dose combination inhalers. Participants take part for around 12 weeks, attending regular clinic check-ups and tracking their breathing at home.
At a glance
What is this study about?
Asthma is a common long-term condition that affects the airways, causing swelling, tightening of the chest, and breathing difficulties. Many people manage their asthma well using everyday preventer inhalers. However, for some adults, standard combination inhalers (which contain steroids and long-acting airway relaxers) do not fully keep symptoms under control. These individuals remain at risk of severe asthma flare-ups, which can disrupt daily life and require urgent medical care.
The LEVANTE trial is testing an experimental inhaled treatment called AZD8630. This medicine is designed to calm airway inflammation in a new way, aiming to stop asthma attacks before they start. Researchers want to understand whether adding this treatment to everyday care helps people breathe more easily and reduces the number of times their asthma flares up.
Because this is a dose-finding study, researchers are testing several different amounts of AZD8630 against a placebo (an identical inhaler with no active medicine). This helps doctors learn the exact dose that provides the best balance of symptom relief and safety. Taking part helps researchers discover if this treatment could become a helpful new option for people with difficult-to-treat asthma.
Key takeaways
- The trial tests a new once-daily inhaled medicine called AZD8630 for uncontrolled asthma.
- It aims to see which dose best reduces asthma flare-ups and improves lung function.
- Participants take the study inhaler for 12 weeks alongside regular clinic health visits.
- Open to adults aged 18 and older whose asthma is not settled by standard preventer inhalers.
- Joining is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with asthma. To be considered, your asthma must still be causing problems—such as frequent breathlessness, chest tightness, or nighttime waking—even though you already take a medium or high dose of daily preventer medicine (a steroid plus a long-acting bronchodilator).
You may also need to have a recent history of asthma flare-ups to take part, showing that your current treatment is not keeping your lungs fully settled.
You might not be able to join if you have other serious, long-term lung conditions (such as severe COPD) or other major medical issues that could make taking part unsafe. The trial doctor will review your full medical history and current medications before confirming if the study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have a confirmed medical diagnosis of asthma.
- I take a daily combination preventer inhaler (steroid plus long-acting bronchodilator).
- I still experience asthma symptoms or recent flare-ups despite using my regular inhalers.
- I am willing to attend regular hospital or clinic appointments for breathing tests and check-ups.
What does participation involve?
If you join this study, you will take an inhaled medicine once every day for 12 weeks. You will be randomly assigned by a computer to receive either one of the doses of AZD8630 or a dummy inhaler (placebo). Neither you nor your study doctor will know which one you are taking, which keeps the results fair.
You will visit the study clinic several times over approximately three to four months. During these visits, the team will check your general health, take blood samples, and test your breathing using simple blow tests (spirometry). Between visits, you will be asked to record your symptoms and use a small handheld meter at home to track your airflow. You will also complete short questionnaires about how your asthma affects your day-to-day life.
Potential risks and benefits
Locations (9)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedSlovakia
- —UnverifiedNetherlands
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedDenmark
- —UnverifiedBelgium
Common questions
Will I have to stop taking my usual asthma inhalers?
No. The trial medicine is usually tested alongside standard asthma care to keep your lungs safe. The study doctor will explain exactly how to take your regular inhalers during the trial.
What is a placebo and why is it used?
A placebo looks and tastes just like the study medicine but contains no active ingredient. It helps doctors prove whether any improvements or side effects are truly caused by the new medicine.
How long will the trial last?
You will take the study inhaler for 12 weeks. Including the initial health screening and a short follow-up period after finishing the medicine, your participation will last around three to four months.
Will I need to pay for any study medicines or tests?
No. All trial medicines, clinic appointments, and tests are provided free of charge. Many trials also help cover reasonable travel expenses to and from the clinic.
Can I leave the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason, and your regular doctor will continue to look after your asthma as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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